BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
FDA device recall Z-1008-2026 · posted 2025-12-31 · Open, Classified
Recall details
- Recalling firm
- Beaver-Visitec International, Inc.
- Reason for recall
- Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
- Action taken
- Beaver-Visitec International (BVI) notified consignees via emailed letter on 12/05/2025. Consignees were informed that the affected units can still be used. A BVI service technician will contact each consignee to schedule a visit. During this visit, the missing ferrites will be installed to restore the equipment to its fully compliant and validated configuration. BVI aims to complete the correction by December 31st, 2025.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HQF
- Quantity affected
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Date initiated
- 2025-12-05
- Date posted
- 2025-12-31
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Leos Laser and Endoscopy System (K240615) | Beaver-Visitec International, Inc. | 2025-04-03 |